ArriVent BioPharma(AVBP) - 2025 Q1 - Quarterly Results

Overview and Recent Highlights ArriVent demonstrated strong Q1 2025 execution by completing pivotal study enrollment, expanding its pipeline, and strengthening its leadership team - The company's lead program, firmonertinib, continues to show potential for EGFR-mutant non-small cell lung cancer (NSCLC), while the newly acquired ADC, ARR-217, is expected to be the first from its ADC pipeline to enter clinical trials[4] - Completed enrollment in the global pivotal Phase 3 FURVENT study for firmonertinib monotherapy in first-line NSCLC with EGFR exon 20 insertion mutations, receiving FDA Breakthrough Therapy Designation for this population[5] - Expanded the pipeline by entering a collaboration with Lepu Biopharma for ARR-217, a CDH17-targeted ADC, securing exclusive development and commercialization rights worldwide outside of greater China[6] - The first IND application for ARR-217 was submitted in China in March 2025, with an initial focus on colorectal, pancreatic, and other GI cancers[8] - Appointed Merdad Parsey, M.D., Ph.D., former Chief Medical Officer of Gilead Sciences, to the Board of Directors in April 2025[11] Upcoming Milestones ArriVent anticipates providing a clinical development plan update for firmonertinib in EGFR PACC mutant NSCLC and expects topline data from the pivotal Phase 3 FURVENT study in 2025 - An update on the development plan for firmonertinib in NSCLC patients with EGFR PACC mutations is expected in Q2 2025, based on maturing data from the FURTHER Phase 1b trial[13] - Topline data from the event-driven global pivotal FURVENT Phase 3 study of firmonertinib is anticipated in 2025[13] First Quarter 2025 Financial Results ArriVent ended Q1 2025 with $205.5 million in cash, projecting funding into H2 2026, while reporting a net loss of $64.4 million, primarily due to a one-time payment and increased clinical expenses Q1 2025 Financial Highlights (vs. Q1 2024, in millions) | Metric | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | Cash, Cash Equivalents & Marketable Securities | $205.5 | - | Expected to fund operations into H2 2026 | | Research & Development (R&D) Expenses | $61.3 | $17.0 | One-time upfront payment to Lepu Biopharma and increased firmonertinib clinical expenses | | General & Administrative (G&A) Expenses | $5.5 | $3.7 | Increased costs for operating as a public company | | Net Loss | $64.4 | $17.4 | Primarily driven by the increase in R&D expenses | Condensed Balance Sheets (Unaudited, in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $49,865 | $74,293 | | Total current assets | $185,785 | $226,979 | | Total assets | $215,495 | $274,942 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $12,953 | $17,274 | | Total liabilities | $12,953 | $17,288 | | Total stockholders' equity | $202,542 | $257,654 | | Total liabilities and stockholders' equity | $215,495 | $274,942 | Condensed Statements of Operations (Unaudited, in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $61,289 | $16,975 | | General and administrative | $5,483 | $3,699 | | Total operating expenses | $66,772 | $20,674 | | Operating loss | ($66,772) | ($20,674) | | Interest and investment income | $2,385 | $3,257 | | Net loss | ($64,387) | ($17,417) | | Net loss per share, basic and diluted | ($1.90) | ($0.70) | Company and Pipeline Overview ArriVent is a clinical-stage biopharmaceutical company focused on developing and commercializing differentiated cancer medicines, leveraging its team to advance firmonertinib and a pipeline of novel therapeutics - ArriVent's mission is to identify, develop, and commercialize differentiated medicines to address unmet medical needs in cancer[15] - The company's strategy focuses on maximizing the potential of its lead candidate, firmonertinib, and advancing a pipeline of novel therapeutics like next-generation antibody drug conjugates (ADCs)[15] About Firmonertinib and Target Indications Firmonertinib is an oral, brain-penetrant EGFR inhibitor active against various NSCLC mutations, holding FDA Breakthrough Therapy Designation and addressing significant unmet medical needs - Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective EGFR inhibitor, effective against both classical and uncommon EGFR mutations like PACC and exon 20 insertions[16] - The drug has received U.S. FDA Breakthrough Therapy Designation for treating previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations[17] - Firmonertinib is currently being studied in a global Phase 3 trial (FURVENT) for first-line NSCLC with EGFR exon 20 mutations and a global Phase 1b study (FURTHER) which includes a cohort for EGFR PACC mutations[18] - Patients with uncommon EGFR mutations, such as exon 20 insertions (~9% of EGFR mutations) and PACC mutations (~12% of EGFR mutations), have limited treatment options and represent a significant area of unmet medical need[19][20]